Adding Amantadine to Pregabalin on Occurrence of Post-thoracotomy Pain Syndrome

NCT06833203 | Completed

• 1 other identifier: AP2310-201-002
• Study Type: interventional
• Target: 60
• Locations: 1 country
• Sites: 1

Brief Summary

This study aims to evaluate the additive effect of Amantadine to Pregabaline in the development of post-thoracotomy pain syndrome.

Conditions

Amantadine; Pregabalin; Post-thoracotomy Pain Syndrome

Outcome Measures

Primary Outcomes (1)

• Incidence of occurrence of post-thoracotomy pain syndrome

  Incidence of occurrence of post-thoracotomy pain syndrome at 12 weeks through according to grading system for neuropathic pain (GSNP). GSNP is as follows: Grade 1 (unlikely), Grade 2 (possible), Grade 3 (probable), and Grade 4 (definite), the patients will be considered positive regarding incidence being in grade 3 or 4.

  12 weeks postoperatively

Secondary Outcomes (7)

• Patient's Quality of life

  12 weeks postoperatively

• Patient's activity level

  12 weeks postoperatively

• Total amount of morphine consumption

  48 hours postoperatively

• Total amount of fentanyl consumption

  Intraoperatively

• Patient Global Impression of Change (PGIC)

  12 weeks postoperatively

Study Arms (2)

Amantadine group

EXPERIMENTAL

Two hours preoperative, patient will receive two capsules, one of them is Amantadine (Amantadine Hydrochloride) 100 mg and the other is Pregabalin (Lyrica) 75 mg and continued on both of them twice daily for 5 days postoperative.

Drug: Amantadine+ Pregabalin

Placebo group

PLACEBO COMPARATOR

Two hours preoperative, the patient will receive two capsules, one of them is pregabalin 75 mg, and the other is a placebo capsule similar to the amantadine capsule and continued on both of them twice daily for 5 days postoperative.

Drug: Pregabalin

Interventions

Amantadine+ Pregabalin DRUG

Two hours preoperative, patient will receive two capsules, one of them is Amantadine (Amantadine Hydrochloride) 100 mg and the other is Pregabalin (Lyrica) 75 mg and continued on both of them twice daily for 5 days postoperative.

Amantadine group

Pregabalin DRUG

Two hours preoperative, the patient will receive two capsules, one of them is pregabalin 75 mg, and the other is a placebo capsule similar to the amantadine capsule and continued on both of them twice daily for 5 days postoperative.

Placebo group

Eligibility Criteria

• Age: 18 Years - 65 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• Age (18-65) years.
• Both sexes.
• American Society of Anesthesiologists (ASA) Physical status II, III.
• Body mass index (BMI): (20-40) kg/m2.
• Cancer patients undergoing posterolateral thoracotomy incision for cancer lung, mesothelioma or other lung resection procedures.

You may not qualify if:

• Patients with known sensitivity or contraindication to drug used in the study.
• History of psychological disorders and/or chronic pain and drug abuse patients.
• Previous administration of antidepressants, anticonvulsants, or opioids before surgery.
• Patient refusal.
• Severe respiratory or cardiac disorders.
• Advanced liver or kidney disease.

Sponsors & Collaborators

• Cairo University: lead

Study Sites (1)

Cairo University

Cairo, Cairo Governorate, 12613, Egypt

Location

MeSH Terms

Interventions

Pregabalin

Intervention Hierarchy (Ancestors)

gamma-Aminobutyric Acid; Aminobutyrates; Butyrates; Acids, Acyclic; Carboxylic Acids; Organic Chemicals; Amino Acids; Amino Acids, Peptides, and Proteins

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: DOUBLE
• Who Masked: PARTICIPANT, OUTCOMES ASSESSOR
• Purpose: PREVENTION
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Assistant Lecturer of Anesthesia, Intensive Care and Pain Medicine, Faculty of Medicine, Cairo University, Cairo, Egypt.

Study Record Dates

• First Submitted: February 13, 2025
• First Posted: February 18, 2025
• Study Start: December 1, 2023
• Primary Completion: May 1, 2025
• Study Completion: May 1, 2025
• Last Updated: January 6, 2026

Record last verified: 2026-01

Data Sharing

• IPD Sharing: Will share
• Shared Documents: STUDY PROTOCOL
• Time Frame: After the end of study for one year.
• Access Criteria: The data will be available upon a reasonable request from the corresponding author

Locations

EG (1)